Abstract
DATA INTEGRITY: AN OBLIGATORY TOOL TO SURVIVE PHARMA INDUSTRY

Sunita Sunil Gagare*, Sunil Krushna Gagare and Dr. Ashish Suresh Jain

ABSTRACT

Medicines and health products are important for addressing health problems and improve quality of lives. They form an indispensable component of health systems in the prevention, diagnosis and treatment of disease and in alleviating disability and functional deficiency. All regulatory bodies (e.g. USFDA, WHO, MHRA) are supporting countries in ensuring equitable access to essential medicines and other health products that are safe, effective and of assured quality. For assured quality the manufacturing should be carried out according to cGMP. The regulatory bodies regularly practice audits and inspections to know cGMP followed or not by respective industries. The assurance is done by auditing data retained by respective industries. Therefore data retained must be integrated.

Keywords: cGMP, ALCOA, data integrity, warning letters.


[Full Text Article]

Login





Forgot Password  |  Register

Indexing

Best Paper Awards

European Journal of Biomedical and Pharmaceutical Sciences (EJBPS) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Article of current issue :

Tangudu Nagabhusana Rao

Download Article : Click here

News & Updation

  • NEW APRIL ISSUE PUBLISHED

    APRIL 2019 Issue has been successfully launched on 1 April 2019

  • EJBPS New Impact Factor

    Its our Pleasure to Inform you that EJBPS Impact Factor has been increased from 4.382 to 4.918 due to high quality Publication at International Level.

  • Index Copernicus Value

    EJBPS Received Index Copernicus Value 77.3, due to High Quality Publication in EJBPS at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Dear Researcher, Article Invited for Publication  in EJBPS coming Issue.

     

UG/PG/Ph.D Research Publication

Research Scholar of UG/PG/Ph.D can Submit their Research Article/Review Article/Case Study/Short Communication for Publication in EJBPS

Downloads

Copyright From

Covering Letter

                        Author Instruction 
 

PLAGERLUM REPORT